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EUDAMED last updated this device on Dec 23, 2021
80584817603087GMANOPOLA FRENO DESTRO PER CARROZZINE EXTREME/EXTREME TR is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by PRAXIS MEDICAL NETWORK SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08058481762988PX17R041(01)08058481762988
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y122499WHEELCHAIRS ACCESSORIES - OTHERIT-MF-000017626The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Italy; available across 1 country total.
Placed on the market in Italy; per-country availability dates not published.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →805848176020677On the marketLETTO ELETTRICO SWING CON 3 SNODI E 4 SEZIONI SU RUOTE REGOLABILE ALTEZZA, RETE DOGHE LEGNO E ACCESSORIATO805848176020677On the marketMANIGLIONE DI SICUREZZA PER VASCA DA BAGNO80584817602106WOn the marketMANOPOLA FRENO SINISTRO PER CARROZZINE EXTREME/EXTREME TR80584817603087GOn the marketMANOPOLA PVC IMPUGNATURA SPINTA PER CARROZZINE EXTREME/EXTREME TR80584817603087GOn the marketMANUBRIO DESTRO PER ROLLATOR ACCIAIO PMN FREE80584817604117AOn the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.No certificate specifically references this device's Basic UDI-DI.